BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE LEAD WIDE SPACED, 90 CM

    MDR report key: 6071067 · Received November 1, 2016

    Report

    Report Number
    1627487-2016-05627
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    August 6, 2016
    Report Date
    October 6, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZF
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.(B)(4).

    Description of Event or Problem · 1

    DEVICE 3 OF 4: REFERENCE MFR REPORT: 1627487-2016-05625, 1627487-2016-05626 & 1627487-2016-05628. IT WAS REPORTED THE PATIENT COMPLAINED THE RIGHT OCCIPITAL (OFF-LABEL) LEAD STOPPED WORKING. A SJM REPRESENTATIVE MET WITH THE PATIENT AND AN IMPEDANCE CHECK SHOWED HIGH IMPEDANCES ON ALL FOUR LEAD CONTACTS. THE REPRESENTATIVE ATTEMPTED TO REPROGRAM THE SCS SYSTEM BUT WAS UNABLE TO RESOLVE THE ISSUE. X-RAYS TAKEN DID NOT SHOW ANY INDICATION THE LEAD HAD MIGRATED. FOLLOW-UP IDENTIFIED THE LEAD WAS REMOVED AND REPLACED WITH A NEW ONE. IMPEDANCES CHECKED NORMAL. THE PATIENT'S SYSTEM WAS PROGRAMMED IN RECOVERY AND ADEQUATE THERAPY WAS RESTORED. IT IS UNDETERMINED WHICH OF THE PATIENT'S FOUR LEADS WAS INVOLVED IN THE EVENT, ALL POSSIBLE DEVICES ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720679 QUATTRODE LEAD WIDE SPACED, 90 CM SCS LEAD GZF ST. JUDE MEDICAL - NEUROMODULATION 3169 5104512

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other MODEL 1192 (X2), SCS ANCHOR| MODEL 3771, SCS IPG